Dao 2011.
| Study characteristics | ||
| Methods | RCT design: nested, 2‐arm parallel‐group trial Total N randomised: 100 Length of follow‐up: no follow‐up Analysis: unclear (method of analysis not explicitly stated; analysis not based on total N randomised; 2 dropouts in intervention arm, 2 dropouts in control arm) |
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| Participants | Location: USA Number of study centres and setting: single centre, Veterans Affairs hospital CAD criteria: patients undergoing first‐time CABG wtihout concomitant valve procedures Depression criteria: BDI‐II of 14 or higher (or anxiety, State–Trait Anxiety Inventory‐Trait score ≥ 40) Other entry criteria: none Exclusion criteria: serious medical illness other than CAD, psychiatric instability (suicidality), schizophrenia, bipolar disorder, active alcoholism or substance abuse, severe cognitive impairment, non‐cardiac illnesses with a poor 1‐year prognosis, previous exposure to CBT within the past year, receiving psychotherapeutic services, unstable antidepressant medication (less than 4 weeks) Treatment N: 48 (22.9% female, mean age: 62.8 (SD: 11.8)) Control N: 49 (20.4% female, mean age: 64.2 (SD: 11.9)) Comparability of groups: no significant baseline differences between groups on demographic variables and measures of depression and anxiety, significantly more diabetes patients in the control group than in the treatment group (Cohen's d = 0.443) |
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| Interventions | Treatment: brief CBT intervention (Managing Anxiety and Depression using Education and Skills (MADES)). MADES uses a manualised approach to address the needs of patients who have CAD with preoperative depression and/or anxiety. Duration of treatment: 2 sessions before surgery, 1 session after surgery, 1 session 5 days after surgery Control: usual care |
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| Outcomes | Review outcomes: depression symptoms (BDI‐II), healthcare and resource utilisation (length of stay), quality of life (12‐item Short Form Health survey) Other outcomes: anxiety symptoms (STAI‐Trait) |
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| Funding | Mental illness research, education and clinical centre | |
| Notes | Mixed study sample (patients with high depression and/or anxiety scores eligible) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Random numbers table |
| Allocation concealment (selection bias) | Unclear risk | Comment: No sufficient information provided on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: No sufficient information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: No sufficient information provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Low drop‐out, but reasons for missing data not mentioned |
| Selective reporting (reporting bias) | Unclear risk | Comment: No study protocol available. Uncertainties regarding data analysis and degrees of freedom (pg.112) |
| Other bias | Unclear risk | Comment: In inpatient studies, therapists and clinic staff are not blind to the patients' allocation, which might impact the inpatient treatment of the intervention and the control group Comment: manualised treatment; all treatment sessions video‐taped and reviewed by lead investigator for adherence and compliance |